Cannula, Suction, Uterine

How Is HGH Classified?

Cannula, Suction, Uterine is FDA product code HGH, Class 2, 21 CFR 884.5070.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 343 days from receipt to decision on them.